aScope™ 4 RhinoLaryngo Slim

Primary DI
05707480158003
Brand
aScope™ 4 RhinoLaryngo Slim
Company
Ambu A/S
Model
510177000
Catalog number
510177000
Device description
aScope 4 RhinoLaryngo Slim Bosma
Published
2022-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EOBNasopharyngoscope (flexible or rigid)

Product Code Classifications

CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05707480157990PackageGS15In Commercial Distribution
05707480158003PackageGS14In Commercial Distribution
05707480157983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707480157990057074801579905707480157990
05707480158003057074801580035707480158003
05707480157983057074801579835707480157983

GMDN Terms

TermDefinition
Flexible video otorhinolaryngoscope, single-useAn endoscope with a flexible inserted portion intended for the visual examination of some or all of the ear (external, middle and inner), nasal passages, paranasal sinuses, pharynx, and/or larynx. It is inserted into the body through the appropriate natural orifice and can be used for treatment if it has a working channel. Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor (not included); it may include an irrigation/suction channel. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+14107686464Purchase_orders@ambuUSA.com
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags

DUNS number
305682023
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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